Single operator exchange biliary catheter

ABSTRACT

Catheter for use in biliary procedures, including a shaft having a proximal end and a distal end. A guidewire lumen is carried by the shaft extending from a location proximal the distal end of the shaft to a location proximate the distal end of the shaft. An opening is included for accessing the guidewire lumen from a location exterior the catheter shaft located distal the proximal end of the shaft. The guidewire lumen may be formed integral the catheter shaft. The catheter may be used in rapid exchange catheter procedures. The catheter may further include a port and channel design including a first opening into the guidewire lumen located proximal the distal end of the shaft, a second opening located proximal the first opening, and a channel extending longitudinally between the first opening and the second opening.

FIELD OF THE INVENTION

[0001] The present invention relates to catheters for use in catheterprocedures accessed through the alimentary canal within the humananatomy and methods of using such catheters. The catheter isparticularly useful in conjunction with an endoscope for accessing thebiliary tree. The present invention includes a catheter having singleoperator exchange or rapid exchange features which permit the use ofshorter guidewires, allow less time consuming procedures, and allow forlarger diameter ancillary lumens within the catheter.

DESCRIPTION OF PRIOR ART

[0002] Endoscopic procedures for treating abnormal pathologies withinthe alimentary canal system and biliary tree (including the biliary,hepatic, and pancreatic ducts) are increasing in number. The endoscopeprovides access to the general area of a desired duct using directvisualization, however, the duct itself must be navigated using acatheter in conjunction with fluoroscopy and guidewires.

[0003] Catheters are known for treatment of targeted anatomical regions.Known methods and devices for using biliary catheters for accessing thebiliary tree for performing catheter procedures are disclosed in Weaveret al., U.S. Pat. No. 5,397,302 and Karpiel, U.S. Pat. No. 5,320,602,the disclosures of which are herein incorporated by reference.

[0004] In general, for treatment of an abnormal pathology within apatient's biliary tree, an endoscope is first introduced into the mouthof the patient. The endoscope includes a proximal end and a distal end,and has a lumen extending longitudinally between the proximal and thedistal ends. The endoscope is guided through the patient's alimentarytract or canal until an opening at the distal end of the endoscope isproximate the location for gaining access to the area to receivetreatment. At this point, the endoscope allows for other components,such as a catheter, to access the targeted area.

[0005] For visualization or treatment within the biliary tree, thedistal end of the endoscope is positioned proximate the papilla of vaterleading to the common bile duct and the pancreatic duct. A catheter isguided through the lumen of my the endoscope until a distal tip of thecatheter emerges from the opening at the distal end of the endoscope.

[0006] The catheter may be used for accessing the biliary tree. Thedistal end of the catheter is guided through the orifice to the papillaof vater (located between the sphincter of oddi) leading to the commonbile duct and the pancreatic duct. A guidewire may be used for furtheraccessing a desired location within the biliary tree. The guidewire isinserted in an opening at a proximal end of the catheter and guidedthrough the catheter until it emerges from the distal end of thecatheter.

[0007] If visualization of the common bile duct is desired, theguidewire is guided into the common bile duct. The catheter is advancedover the guidewire, as previously described, until the distal end of thecatheter is positioned in the common bile duct at the desired location.The catheter is now in position for delivery of contrast media forfluoroscopic visualization of anatomical detail within the common bileduct. Once the guidewire is placed, it is desirable to maintain positionof the guidewire during subsequent catheter procedures, includingcatheter exchange procedures.

[0008] Present biliary endoscopic procedures include the use ofmulti-lumen catheters for endoscopic retrogradecholangiopancreatography, endoscopic retrograde sphincterotomy, the useof balloon catheters having retrieval balloons, and other therapeuticand diagnostic procedures. As described in general above, these presentbiliary endoscopic procedures are performed using guidewire techniques.The present devices utilized in these procedures are at least 180 cmlong since they pass through the endoscope, which is commonly at least150 cm long. Therefore, when using a standard catheter having aguidewire lumen extending the full length of the catheter, guidewiresused during these procedures must be at least 400 cm in length toaccommodate the exchanging of different devices while maintaining accessand position within the biliary tree. The exchange of devices over a 400cm guidewire is both time consuming and cumbersome.

[0009] Due to the length of the guidewire, physicians require at leasttwo assistants in the room to perform the biliary endoscopic procedure.Typically, one assistant is responsible for the patient anddevice-related concerns, while the other assistant is responsible forthe guidewire. The additional hands required due to the length of theguidewire results in a relatively more time consuming and costlyprocedure.

[0010] It is desirable to have an exchange catheter suitable for usewithin the alimentary canal for accessing targeted anatomical regions,such as the biliary tree, having features which facilitate rapidexchange and allow an exchange procedure to be performed by a singleoperator. It is desirable to have a biliary exchange catheter which maybe used in connection with a shorter guidewire, and requires lesspersonnel for performing biliary procedures. It is desirable to have abiliary exchange catheter which limits the amount of guidewire overwhich the catheter must travel.

[0011] It is also desirable to have a biliary rapid exchange catheterwhich may be convertible for use between conventional guidewiretechniques and rapid exchange guidewire techniques. It is desirable tohave a biliary rapid exchange catheter which is easily removable fromthe guidewire, and adaptable for use with most catheter systems usedwithin the alimentary canal.

SUMMARY OF THE INVENTION

[0012] The present invention relates to a biliary catheter for use inbiliary endoscopic procedures which incorporates rapid exchange catheterfeatures. Rapid exchange features include an effective guidewire lumenwhich is much shorter than the overall catheter length to facilitaterapid exchange of the device over the guidewire.

[0013] In one preferred embodiment, the present invention is an improvedcatheter for use in biliary procedures which includes a shaft having aproximal end and a distal end. The improvement includes a guidewirelumen carried by the shaft extending from a location proximal of thedistal end of the shaft to a location proximate the distal end of theshaft. Means are provided for accessing the guidewire lumen from alocation exterior to the catheter shaft, located a substantial distancedistal of the proximal end of the shaft.

[0014] The guidewire lumen may be formed integral with the shaft. Themeans for accessing the guidewire lumen may include an opening extendingthrough the wall of the catheter shaft. Additionally, the wall of thecatheter shaft defined by the guidewire lumen may include a relativelyweak area extending longitudinally between the opening and the distalend of the shaft. The weak area may be perforated. The catheter mayfurther include a tool for guiding a guidewire through the opening intothe guidewire lumen.

[0015] In a further preferred embodiment, the means for accessing thelumen may include a slit in the wall of the catheter shaft. An ancillarylumen may extend between the catheter proximal end and the catheterdistal end.

[0016] In one embodiment, the means for accessing the guidewire lumenincludes a first opening or intermediate guidewire port through the wallof the catheter shaft into the guidewire lumen located proximal of thedistal end of the shaft. A second opening or proximal guidewire portinto the guidewire lumen is located proximal of the first opening. Achannel extends between the first opening and the second opening. Thechannel includes a longitudinal opening to the exterior of the cathetershaft extending between the first opening and the second opening incommunication with the guidewire lumen. The longitudinal openingpreferably is smaller than the diameter of a guidewire used therewith.

[0017] In another embodiment, the present invention is a biliary rapidexchange catheter. The biliary rapid exchange catheter includes abiliary catheter sized for passage within an endoscope including a shafthaving a proximal end and a distal end. The biliary catheter includes atubular member having a proximal end, a distal end, and a guidewirelumen extending longitudinally therethrough which extends between alocation proximate the distal end of the shaft (a distal port) to alocation proximal of the distal end of the shaft (a proximal port). Theproximal port is provided in communication with the guidewire lumen, ata location proximal of the distal end of the shaft.

[0018] The proximal port may be located at the proximal end of thetubular member. The guidewire lumen may then extend between the proximalend and the distal end of the shaft. The guidewire lumen would theninclude a weakened area extending longitudinally between the proximalport and the distal end of the shaft. The biliary catheter may furtherinclude an ancillary lumen extending between the proximal end and thedistal end of the shaft.

[0019] The biliary catheter may alternatively include an intermediateport into the guidewire lumen at a longitudinal location between theproximal port and the distal end of the shaft or distal port. Means areincluded extending longitudinally between the proximal port and theintermediate port for allowing a guidewire to be moved between alocation exterior of the guidewire lumen to a location within theguidewire lumen between the proximal and intermediate ports. The meansfor allowing the guidewire to be moved between a location exterior theguidewire lumen and within the guidewire lumen include an open channelextending longitudinally between the proximal port and the intermediateport.

[0020] The means for allowing the guidewire to be moved between alocation exterior the guidewire lumen and within the guidewire lumen mayinclude a weakened portion within the tubular member extendinglongitudinally between the proximal port and the intermediate port. Theweakened portion may be perforated.

[0021] In another embodiment, the present invention includes a method ofpositioning a biliary catheter including a shaft having a proximal endand a distal end, within a patient's alimentary canal. The methodincludes the step of providing a catheter with a guidewire lumentherein. The guidewire lumen extends from a location proximal of thedistal end of the shaft to a location proximate the distal end of theshaft. A port is provided through a sidewall of the shaft into theguidewire lumen. The port is located distal of the proximal end of theshaft. The method further includes the step of moving a guidewirethrough the port, relative to the shaft. The method may further includethe step of advancing the catheter over the guidewire.

[0022] In another embodiment, the present invention includes a method ofexchanging a catheter during a biliary endoscopic procedure. The methodincludes the step of passing an endoscope having a lumen extendinglongitudinally therethrough, through a patient's mouth into thealimentary canal. A distal end of the endoscope is positioned proximatean opening into the biliary tree. A guidewire is passed through thelumen of the endoscope.

[0023] A catheter is provided having a guidewire lumen carried by theshaft, extending from a location proximal of a distal end of the shaftto a location proximate the distal end of the shaft. A first opening isincluded into the guidewire lumen, located distal of the proximal end ofthe shaft. The catheter is advanced over the guidewire, wherein aproximal end of the guidewire exits the first opening.

[0024] The method may further include retracting the catheter over theguidewire. In one embodiment, wherein the catheter is retracted over theguidewire until the opening is outside the proximal end of theendoscope, the catheter has a weakened area extending longitudinallybetween the opening and the distal end of the catheter. The methodfurther comprises the step of peeling the catheter away from theguidewire.

[0025] The catheter may further include a second opening or intermediateopening into the guidewire lumen. A channel extends longitudinallybetween the first opening and the second opening. The method furthercomprises the step of passing the guidewire radially through the channelopening while inserting or retracting the catheter until the guidewireexits the second opening.

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The invention will be further described with reference to theaccompanying drawings, wherein like numbers refer to like parts inseveral views and wherein:

[0027]FIG. 1 is a partial elevational view of a catheter in accordancewith the present invention having a guidewire lumen for facilitatingrapid catheter exchange with a guidewire passing therethrough;

[0028]FIG. 1A is a cross-sectional view of the catheter of FIG. 1 takenalong line 1A-1A;

[0029]FIG. 1B is a cross-sectional view of the catheter of FIG. 1 takenalong line 1B-1B;

[0030]FIG. 1C is a cross-sectional view of the catheter of FIG. 1 takenalong line 1C-1C;

[0031]FIG. 1D is a cross-sectional view of an alternative embodiment ofthe catheter of FIG. 1 in accordance with the present invention, alsotaken along line 1C-1C;

[0032]FIG. 1E is a partial elevational view of an alternative embodimentof the catheter in accordance with the present invention;

[0033]FIG. 1F is a cross-sectional view of the catheter of FIG. 1E takenalong line 1F-1F;

[0034]FIG. 2 is a partial elevational view of another embodiment of thecatheter in accordance with the present invention;

[0035]FIG. 3 is a partial elevational view of another embodiment of thecatheter in accordance with the present invention;

[0036]FIG. 3A is a cross-sectional view of the catheter of FIG. 3 takenalong line 3A-3A;

[0037]FIG. 3B is a cross-sectional view of the catheter of FIG. 3 takenalong line 3B-3B;

[0038]FIG. 4 is a partial elevational view of another embodiment of thecatheter in accordance with the present invention;

[0039]FIG. 4A is a cross-sectional view of the catheter of FIG. 4 takenalong line 4A-4A;

[0040]FIG. 4B is a cross-sectional view of the catheter of FIG. 4 takenalong line 4B-4B;

[0041]FIG. 5 is a partial elevational view of another embodiment of thecatheter in accordance with the present invention;

[0042]FIG. 5A is a cross-sectional view of the catheter of FIG. 5 takenalong line 5A-5A;

[0043]FIG. 6 is a different partial elevational view of the catheter ofFIG. 5 having a guidewire disposed therein;

[0044]FIG. 6A is a cross-sectional view of the catheter of FIG. 6 takenalong line 6A-6A showing the guidewire received within the lumen of FIG.5;

[0045]FIG. 7 is a partial elevational view of a catheter assemblyshowing a guidewire loading tool for use in conjunction with thecatheter of FIGS. 5 and 6;

[0046]FIG. 7A is an alternative partial elevational view of the catheterassembly of FIG. 7 showing an application of the present invention;

[0047]FIG. 7B is a partial cross-sectional view of the catheter of FIG.7 taken along line 7B-7B, showing a first guidewire tool position;

[0048]FIG. 7C is a partial elevational view of a catheter assemblyshowing an application of the present invention;

[0049]FIG. 7D is a partial cross-sectional view of the catheter of FIG.7 taken along line 7B-7B showing a second guidewire tool position;

[0050]FIG. 7E is a partial elevational view of a catheter assemblyshowing an application of the present invention;

[0051]FIG. 7F is a partial cross-sectional view of the catheter of FIG.7 taken along line 7B-7B, showing a third guidewire tool position;

[0052]FIG. 7G is a partial elevational view of a catheter assemblyshowing an application of the present invention;

[0053]FIG. 7H is a partial cross-sectional view of the catheter of FIG.7 taken along line 7B-7B, showing a fourth guidewire tool position; and

[0054]FIG. 8 is a partial elevational view of a catheter showing anotherapplication of the present invention;

[0055]FIG. 9 is a partial elevational view of a catheter showing anotherapplication of the present invention;

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0056]FIG. 1 shows a partial elevational view of a catheter assembly 30in accordance with the present invention. The catheter assembly 30 isused in catheter procedures for accessing targeted anatomical regionsthrough the alimentary canal. The present invention incorporatesfeatures which allow rapid exchange of catheter by a single operator.The catheter of the present invention allows shorter length guidewiresto be used, resulting in procedures which require less medicalpersonnel, are less time consuming, and less costly. Additionally, thepresent invention is adaptable to most catheter devices used forcatheter procedures within the alimentary canal.

[0057] Catheter assembly 30 includes a catheter 32 having a guidewire 34passing through a portion thereof. Catheter 32 includes a shaft 36having a proximal end 38 and a distal end 40. Operably connected to theproximal end 38 of the shaft 36 is a hub assembly 42. Hub assembly 42couples to ancillary devices allowing access to a lumen within shaft 36.Shaft 36 is preferably formed in an extrusion process. Shaft 36 may beformed of an extruded polymeric material. In one embodiment, thepreferred polymeric material is polytetrafluoroethylene, polyether blockamide, nylon or a combination or blend of these. Catheters which arecontemplated include, but are not limited to, cannulas, sphinctertomes,cytology devices, and devices for stone retrieval and stent placement.

[0058] Shaft 36 is a generally tubular shaped member having a generallyuniform outer shape at its proximal end. Shaft 36 may be sized forslidable passage through the lumen of an endoscope. Shaft 36 includes adistal taper 44 which tapers to a tip region 46. Tip region 46 mayinclude high contrast, color coded distal markers 48, and a radiopaquedistal tip 50 for fluoroscopic visualization of tip region 46 during acatheter procedure.

[0059] Shaft 36 further includes a proximal port or opening 52 locatedproximal of distal end 40. Proximal opening 52 allows access to shaft 36for passage of guidewire 34 through shaft 36. FIG. 1A is across-sectional view of shaft 36 taken along line 1A-1A at a locationproximal of proximal opening 52. Proximal to proximal opening 52,guidewire 34 is positioned adjacent the catheter shaft 36.

[0060] Extending longitudinally between the shaft proximal end 38 anddistal end 40 is an ancillary lumen 54 and an ancillary lumen 56.Ancillary lumen 54 and ancillary lumen 56 may be injection lumens,allowing for high contrast media flow capability for bubble-freeopacification and for excellent visualization of a desired anatomicalregion. Additionally or alternatively, ancillary lumen 54 and/orancillary lumen 56 may be used for other ancillary devices, such as acutting wire lumen or a retrieval balloon lumen.

[0061] Referring to FIG. 1B, a cross-sectional view of shaft 36 takenalong line 1B-1B of FIG. 1 is shown. A guidewire lumen 58 extendsbetween proximal opening 52 and distal end 40. Guidewire 34 may enterguidewire lumen 58 at proximal opening 52. Guidewire lumen 58 is sizedfor slidable receipt and passage of guidewire 34 through guidewire lumen58. Referring to FIG. 1C, guidewire lumen 58 extends through distaltaper 44 and tip region 46.

[0062] Although it is recognized that proximal opening 52 may be locatedat any location distal of proximal end 38, proximal opening 52 ispreferably located between 10 and 40 cm from distal end 40. Guidewirelumen 58 is a tubular member which is carried adjacent shaft 36ancillary lumen 54 and ancillary lumen 56. Guidewire lumen 58 may beformed integral with shaft 36, or alternatively, guidewire lumen 58 maybe part of a separate tubular member which is coupled to the shaft 36 asshown in FIG. 1D.

[0063] Now referring to FIGS. 1E and 1F, an alternative embodiment ofthe catheter depicted in FIG. 1 is illustrated. The catheter shaft 36 ofFIG. 1E incorporates a proximal guidewire opening which, in conjunctionwith the catheter, forms a circular cross section which allows for easyinsertion of the guidewire. As depicted in FIG. 1F, the guidewire lumen58 can include a larger proximal opening which funnels down to the sizeof the guidewire lumen 58 which extends distal to the distal end of thecatheter shaft 36.

[0064] Guidewire lumen 58 allows rapid exchange of catheter 32 when analternative catheter is necessary during a procedure. Shorter lengthguidewires may be used since guidewire 34 does not pass through proximalend 38 and hub assembly 42, but rather exits the catheter shaft 36 atproximal opening 52 located substantially distal from proximal end 38.The unique catheter construction in accordance with the presentinvention will reduce catheter therapeutic and diagnostic procedure timesince catheter device exchanges may be performed relatively more easilyand quickly by a single operator. Additional personnel and timeassociated with maintaining the placement of a conventional(approximately 400 cm) guidewire within the targeted anatomical regionis eliminated, reducing the overall costs of the procedure.

[0065] Referring to FIG. 2, a partial elevational view of a distalportion of catheter shaft 36 is shown. Shaft 36 may further include aweakened area 60. The weakened area 60 extends longitudinally alongguidewire lumen 58 (not shown) between proximal opening 52 and distalend 40.

[0066] When guidewire 34 is positioned within guidewire lumen 58,weakened area 60 allows guidewire 34 to be removed from guidewire lumen58 by “peeling away” guidewire 34 from catheter shaft 36. Weakened area60 may include less catheter material than the remaining portion ofshaft 36, or may be perforated, cut or slit.

[0067] Another embodiment of the present invention is shown generally inFIG. 3. FIG. 3 is a partial elevational view of catheter 32, which maybe a “convertible” catheter design. In catheter 32, shaft 36 includes anopening 52 which is a skive port 62 for access to guidewire lumen 58.Catheter 32 is a convertible catheter design in that an existingcatheter may be modified to include skive port 62. As a convertiblecatheter design, skive port 62 is formed by cutting an opening in shaft36 for access to guidewire lumen 58. It is recognized that catheter 32may be manufactured to include skive port 62.

[0068] Referring to FIG. 3A, proximal to skive port 62 catheter shaft 36includes ancillary lumen 54 and ancillary lumen 56 as previouslydescribed herein. Additionally, shaft 36 includes guidewire lumen 58extending between proximal end 38 and distal end 40, including betweenskive port 62 and proximal end 38. Referring to FIG. 3B, guidewire 34may access guidewire lumen 58 at skive port 62 and extend through theguidewire lumen 58 emerging from distal end 40.

[0069] With this embodiment, conventional guidewire techniques may beused for positioning and exchanging catheter 32 within a patient'salimentary canal system. Further, the convertible catheter designincorporates features which allow rapid exchange of catheters by asingle operator. Skive port 62 opening 52 allows catheter 32 to be usedin rapid exchange of catheter 32 when an alternative catheter isnecessary during a procedure. By allowing the guidewire 34 to enter theguidewire lumen 58 at a location distal from the proximal end 38,relatively shorter guidewires may be used during catheter procedureswithin the alimentary canal system, resulting in a more efficient andless costly procedure.

[0070] It is recognized that other means for accessing the guidewirelumen 58 at a location distal from the proximal end 38 are contemplatedwithin the scope of the present invention. Referring to FIG. 4, aweakened location or slit 64 is shown within area A for accessing theguidewire lumen 58. Referring to FIG. 4A, proximal to the slit 64, theguidewire may be positioned adjacent the catheter shaft 36. Guidewire 34enters guidewire lumen 58 at slit 64 for passage of guidewire 34 throughthe guidewire lumen 58. Referring to FIG. 4B, guidewire 34 is slidablycontained within the guidewire lumen 58 at a location distal of the slit64. With this embodiment, since guidewire lumen 58 may extendlongitudinally from the proximal end 38 to the distal end 40,conventional guidewire techniques may also be used during the catheterprocedure.

[0071] Referring to FIG. 5, another embodiment of the catheter of thepresent invention incorporating features which allow rapid exchange ofcatheters by a single operator is generally shown. The catheter assembly30 includes a “port and channel” configuration. For access to guidewirelumen 34, shaft 36 includes a first opening or intermediate port 66located proximal of the distal end 40. A second opening or proximal port68 is located proximal of the intermediate port 66 and proximal ofdistal end 40. Extending between the intermediate port 66 and proximalport 68 is a longitudinal channel 70.

[0072] Guidewire lumen 34 extends longitudinally between proximal end 38and distal end 40. Referring to FIG. 5A, channel 70 is located withinthe wall of catheter shaft 36, providing access to guidewire lumen 58between proximal port 68 and intermediate port 66. Preferably, channel70 includes a radial opening extending between proximal port 68 andintermediate port 66. It is also recognized that channel 70 may be aweakened area within the wall of the catheter shaft, a perforated area,or a slit which extends between proximal port 68 and intermediate port66.

[0073] In one embodiment, intermediate port 66 is located near distalend 40, and proximal port 68 is located near proximal end 38. Referringto FIG. 6, the distal end of guidewire 34 may be inserted within theintermediate port 66 (not shown), passing through guidewire lumen 58 andemerging from the catheter 32 distal end 40. Referring also to FIG. 6A,guidewire 34 may then be snapped through channel 70 into guidewire lumen58 with the proximal end of the guidewire 34 exiting the proximal port68. With this “port and channel” design, both conventional and rapidexchange techniques may be used.

[0074]FIG. 7 shows a partial elevational view of the catheter assembly30 in accordance with the present invention including one preferredembodiment of a tool 59. Tool 59 aids in guiding guidewire 34 during acatheter procedure. Tool 59, shown positioned over catheter shaft 36,includes a body member 80 having a generally tubular shape. The bodymember 80 includes a proximal end 82, a distal end 84, and a lumen 86extending longitudinally therethrough. The lumen 86 is sized forslidable receipt of catheter shaft 36.

[0075] Located near the proximal end 82 of tool 59 is a grippingmechanism 88. Gripping mechanism 88 aids a user in gripping tool 59during use of tool 59. Located proximal to the distal end 84 of tool 59is guidewire opening 90. Guidewire opening 90 is brought incommunication with a desired port or opening along the catheter 36 shaftto aid in guiding a guidewire (such as guidewire 34) into guidewirelumen 58.

[0076] Referring to FIG. 7A, tool 59 further includes a lockingmechanism 92. Referring to FIG. 7B, which is a cross-sectional view ofthe tool 59 shown in FIG. 7A, locking mechanism 92 further includes alocking head 94, a stem 96 and an operating mechanism 100.

[0077] Operating mechanism 100 is located exterior of body member 80.Operating mechanism 100 is coupled to stem 96. Stem 96 extends throughan opening 102 in body member 80, and is coupled to locking head 94.Locking mechanism 92 is moveable within an interior chamber 104 of bodymember 80.

[0078] More specifically, by applying pressure externally to operatingmechanism 100, locking head 94 is moveable within interior chamber 104for moving tool 59 between a locked and unlocked position relative tocatheter shaft 36. When positioned in a locked position (as shown inFIG. 7B), tool 59 is locked onto catheter shaft 36. When in an unlockedposition, tool 59 allows catheter shaft 36 to pass through lumen 86 andmove freely relative to tool 59.

[0079] Referring again to FIG. 7A and FIG. 7B, tool 59 is shown in alocked position. In this position, locking head 94 friction locks thecatheter shaft 36 within lumen 86. As indicated by directional arrow106, tool 59 allows the catheter shaft 36 to be held stationary, whileguidewire 34 is inserted into the guidewire lumen 58 through an openingor port in the catheter shaft 36 (such as proximal port 66 orintermediate port 68 in FIG. 7).

[0080] Referring to FIG. 7C, once guidewire 34 is in place during abiliary procedure, it may be necessary to remove the catheter shaft 36.By applying pressure to operating mechanism 100, locking mechanism 92may be moved to an unlocked position, as shown in FIG. 7D. The guidewire34 may be held stationary, and the catheter shaft 36 may be removed(indicated by directional arrow 108), allowing the catheter shaft 36 tobe removed or “peeled away” from the guidewire 34 while the guidewire 34remains positioned within the patient's body.

[0081] Referring to FIG. 7E, tool 59 may be used to back load cathetershaft 36 onto guidewire 34 positioned within the patient's biliary tree.Referring to FIG. 7F, to start back loading catheter shaft 36 ontoguidewire 34, tool 59 is positioned over the desired opening (such asintermediate opening 68 in the embodiment shown in FIG. 7) and locked tocatheter shaft 36 in a deflected position.

[0082] By applying pressure to operating mechanism 100 (indicated bydirectional arrow 110), locking head 94 locks catheter shaft 36 in a“deflected” position. By locking the tool 59 to catheter shaft 36 in adeflected position, tool 59 aids in back loading the catheter shaft 36onto guidewire 34.

[0083] To start back loading, the distal end 40 of catheter shaft 36 isinserted over the proximal end of guidewire 34. As catheter shaft 36passes over the guidewire 34, the proximal end of guidewire 34 is guidedthrough the catheter intermediate opening 66, through guidewire opening90, exiting tool 59.

[0084] Referring to FIG. 7G, once the proximal end of guidewire 34 isguided through the intermediate opening 66, catheter shaft 36 maycontinue to be back loaded onto guidewire 34. Referring to FIG. 7H, byreturning locking mechanism 92 to an unlocked position, guidewire 34 maybe held stationary relative to tool 59, and catheter shaft 36 movesfreely within lumen 86 (indicated by directional arrow 112), allowingcatheter shaft 36 to be loaded onto guidewire 34. As catheter shaft 36is loaded onto guidewire 34, the tool 59 aids in guiding guidewire 34through channel 70 into the guidewire lumen 58 until guidewire 34 exitsproximal opening 68.

[0085] Tool 59 aids in guiding guidewire 34 through opening 52 (shown inFIG. 1) or “port and channel” proximal port 68, channel 70, andintermediate port 66 (as shown in FIG. 7). Tool 59 allows for gradualintroduction of guidewire 34 into the guidewire lumen 58 during anendoscopic procedure. As previously described herein, it is recognizedthat tool 59 may be used to hold catheter shaft 36 stationary whileguidewire 34 is being advanced or retracted during a catheter procedure.Alternatively, it is recognized that tool 59 may be used to holdguidewire 34 in place during a rapid exchange procedure or duringadvancement or retraction of catheter shaft 36 over guidewire 34.

[0086] It is also recognized that a locking device (not shown) may belocated proximate first port 66 or proximate second port 68 to aid inguiding guidewire 34 into guidewire lumen 58 during an endoscopicprocedure. The locking device can be similar to the tool 59 aspreviously described herein. Additionally, it is recognized that tool 59may be used to hold the catheter shaft 36 in place while guidewire 34 isbeing advanced or retracted during a catheter procedure. Alternatively,it is recognized that tool 59 may be used to hold guidewire 34 in placeduring a rapid exchange procedure, or during advancement or retractionof catheter shaft 36 over guidewire 34.

[0087] It is recognized that the rapid exchange technology of thepresent invention may be utilized in different types of catheterassemblies used within the alimentary canal. Referring to FIG. 8,catheter assembly 30 is used as a rapid exchange retrieval balloonsystem used for stone retrieval or isolated visualization techniques.Ancillary lumens 54 and 56 (FIG. 1A) are available for passage ofretrieval balloon catheter 72 having a balloon 74 located at its distalend, and for passage of dye injection apparatus 76. With thisembodiment, the guidewire lumen may be accessed using conventionalguidewire techniques through the proximal end of catheter 32 or usingrapid exchange techniques.

[0088] Referring to FIG. 9, the rapid exchange designs of the presentinvention may be used for other alimentary canal catheter applications,such as a rapid exchange sphincter catheter used for endoscopicretrograde sphincterotomy, shown using a cutting wire apparatus 78.Again, the guidewire lumen (not shown) may be accessed by conventionalguidewire techniques at the proximal end, or alternatively, using therapid exchange technology of the present invention.

[0089] The rapid exchange catheter of the present invention is amulti-lumen catheter. With this invention, the guidewire lumen isisolated from the ancillary lumens allowing for exceptional contrastflow for high quality opacification without the need for guidewireremoval. Treatment and therapeutic devices, such as retrieval ballooncatheters or catheters having cutting apparatus may be advanced throughthe ancillary lumens, without interference of a guidewire located withinthe guidewire lumen. Additionally, isolation of the guidewire lumen fromthe contrast lumen minimizes the risk of bubble formation duringcontrast flow and produces a contrast-free guidewire surface forefficient device exchanges.

[0090] The rapid exchange biliary catheter of the present inventionresults in less time consuming and less costly catheter procedures,since a much shorter guidewire may be used and additional personnel arenot required to maintain the guidewire position during a catheterprocedure. In use in a typical endoscopic procedure, an endoscope isfirst introduced into the mouth of a patient and is guided through thepatient's alimentary canal. Specifically, the endoscope is guided downthe esophagus, through the stomach, past the pyloric sphincter of thestomach and into the duodenum. The endoscope has a lumen extendinglongitudinally between its proximal end and the distal end.

[0091] The endoscope is guided through the alimentary canal until thedistal end of the endoscope is proximate the target area within theanatomy to receive treatment. In an endoscopic biliary procedure, theendoscope is guided into the duodenum until the opening at the distalend of the endoscope is proximate the papilla of vater. The papilla ofvater is located between the sphincter of oddi, which leads to thecommon bile duct, hepatic, and pancreatic ducts. The proximate end ofthe endoscope extends and remains outside the mouth of the patient.

[0092] With general reference to the various embodiments shown in FIGS.1-7, once the endoscope is in proper position, guidewire 34 is insertedinto the proximal opening of the endoscope and advanced through thelumen of the endoscope until guidewire 34 distal end emerges from theopening at the distal end of the endoscope. The distal tip of guidewire34 may be guided through the orifice leading to the papilla of vater foraccess into the biliary tree.

[0093] Once the distal end of guidewire 34 is positioned within thebiliary tree (including the common bile, hepatic or pancreatic ducts),rapid exchange catheter 32, in accordance with the present invention,may be back-loaded onto guidewire 34. Distal end 40 of catheter 32 isloaded onto the proximal end of guidewire 34. Rapid exchange catheter 32is advanced over guidewire 34, until the distal end 40 exits the distalend of the endoscope. Within the endoscope, distal from opening 52, theguidewire passes through guidewire lumen 58, and proximal to opening 52,the guidewire is positioned adjacent catheter shaft 36.

[0094] Distal end 40 of catheter 32 tracks guidewire 34 through theorifice leading to the papilla of vater, and into the desired duct, suchas the common bile duct. Once distal end 40 of catheter 32 is inposition in the common bile duct, catheter procedures may be performed,such as injecting a contrast media, such as radiopaque dye, throughancillary lumen 54 and ancillary lumen 56 into the common bile duct forvisualization of the duct.

[0095] Since the proximal end of guidewire 34 exits the guidewire lumen58 at a location distal of the catheter 32 proximal end 38, shorterguidewires may be used by the physician as previously described herein.In one embodiment, a 250 cm guidewire is used. The use of the shorterguidewire eliminates many disadvantages of using longer guidewires whichwere approximately 400 cm in length, while maintaining or improving theefficiency and outcome of the procedure.

[0096] Alternatively, if a guidewire 34 has not been previouslypositioned within the biliary tree, rapid exchange catheter 32 may beused to establish access to the targeted anatomy location within thealimentary canal. Catheter 32 is passed through the lumen of theendoscope, until distal end 40 is guided up through the orifice into thepapilla of vater, and into the desired duct, such as the common bileduct. The guidewire 34 is then inserted into the endoscope lumenadjacent catheter 32. Guidewire 34 is advanced through opening 52 intoguidewire lumen 58 to the targeted area, such as the common bile duct.

[0097] Once guidewire 34 is in position, and the desired catheterprocedure has been completed, rapid exchange catheter 32 can beexchanged or removed from the endoscope, while leaving guidewire 34 inposition for other catheter procedures. Catheter 32 is removed fromguidewire 34 by tracking catheter 32 back over guidewire 34 untilguidewire lumen 58 is retracted completely off the proximal end ofguidewire 34.

[0098] Referring to the embodiment of FIG. 2, if catheter 32 includesweakened area 60, once opening 52 is outside of the proximal end of theendoscope, catheter 52 may be “peeled away” from guidewire 34 untilcatheter 32 is completely removed from guidewire 34.

[0099] Although catheter 32 is removed from guidewire 34, the positionof guidewire 34 is maintained within the targeted anatomy. Other rapidexchange procedures may be performed, such as the catheter assembly 30of FIG. 8 or FIG. 9 without having to re-establish a path to the targetarea of the anatomy to receive therapeutic or diagnostic treatment.These catheter assemblies may be loaded onto guidewire 34 using the samerapid exchange procedures as previously described herein.

[0100] If a convertible catheter (as shown in FIG. 3) or “slit” catheter(as shown in FIG. 4) are used, the physician may alternate betweenconventional and rapid exchange guidewire procedures since guidewirelumen 58 within these devices extend from distal end 40 to proximal end38.

[0101] If catheter 32 further includes a “port and channel” typeconfiguration (FIG. 5), as rapid exchange catheter 32 is back-loadedonto guidewire 34, the proximal end of guidewire 34 exits the distal orfirst port 66 of the catheter 32. As catheter 32 is advanced overguidewire 34, the guidewire is “snapped” into guidewire lumen 58 viachannel 70. When catheter 32 is fully advanced over guidewire 34,guidewire 34 exits guidewire lumen 58 through proximal or second port68.

[0102] With the “port and channel” technology, when catheter 32 ispositioned within the endoscope, guidewire 34 is not located adjacentcatheter shaft 36, but rather is positioned within guidewire lumen 58.Guidewire 34 exits guidewire lumen 58 at second port 68, which islocated outside of and proximal to the proximal end of the endoscope.With this configuration, additional working space is not required forguidewire 34 to lie adjacent catheter 32 within the endoscope lumen.This configuration allows for more room within the working space of theendoscope, allowing for larger ancillary lumens within catheter 32itself.

[0103] The “port and channel” catheter configuration may be manufacturedas a catheter unit, or, alternatively, existing catheter devices may beconverted or modified to include the “port and channel” design. Uponretraction of catheter 32 from the endoscope, guidewire 34 is peeledaway from the endoscope via channel 70 until first port 66 is retractedfrom the proximal end of the endoscope. The short length of catheter 32distal of first port 66, which does not include access channel 70, isretracted completely off the proximal end of guidewire 34.

[0104] As previously described herein, if guidewire 34 is not inposition within the targeted anatomical location, the rapid exchangecatheter 32 may be used to cannulate the path to the targeted locationwithin the patient's anatomy, such as cannulating the papilla of vaterfor access to the ducts of the biliary tree. As previously describedherein, the catheter may then be removed, and other rapid exchangedevices using the technology of the present invention may be exchangedover the guidewire since the guidewire remains in position within thebiliary tree.

[0105] As previously described herein, guidewire lumen 58 may be atubular member which is extruded integral the catheter 32 shaft, oralternatively, guidewire lumen 58 may be a separate tubular member whichis coupled to catheter shaft 36. Although in one preferred embodimentguidewire lumen 58 is a tubular member which is located proximate distalend 40 of the catheter shaft 36, it is recognized that guidewire lumen58 may be formed anywhere along shaft 36, may be an extension of shaft36 coupled to the distal end 40, or guidewire lumen 58 may run theentire length of shaft 36.

[0106] It will be understood, that this disclosure is, in many respects,only illustrative. Changes may be made in details, particularly inmatters of shape, size, material, and arrangement of parts withoutexceeding the scope of the invention. Accordingly, the scope of theinvention is as defined within the language of the appended claims.

What is claimed:
 1. In a catheter for use in biliary proceduresincluding a shaft having a proximal end and a distal end, theimprovement comprising: a guidewire lumen carried by the shaft extendingfrom a location proximal the distal end of the shaft to a locationproximate the distal end of the shaft; and means for accessing theguidewire lumen from a location exterior to the catheter shaft, locateddistal the proximal end of the shaft.
 2. The catheter of claim 1 whereinthe guidewire lumen is formed integral the shaft.
 3. The catheter ofclaim 1, wherein the means for accessing the guidewire lumen includes anopening extending through the wall of the catheter shaft into theguidewire lumen.
 4. The catheter of claim 3, further wherein the wall ofthe catheter shaft defined by the guidewire lumen includes a relativelyweak area extending longitudinally between the opening and the distalend of the shaft.
 5. The catheter of claim 4, wherein the weak area isperforated.
 6. The catheter of claim 3, further comprising a tool forguiding a guidewire into the opening.
 7. The catheter of claim 1,wherein the means for accessing the lumen includes a slit in the wall ofthe catheter shaft.
 8. The catheter of claim 1, further including anancillary lumen extending between the catheter proximal end and thecatheter distal end.
 9. The catheter of claim 1, wherein the means foraccessing the guidewire lumen includes: a first opening through the wallof the catheter shaft into the guidewire lumen located proximal thedistal end of the shaft; a second opening through the wall of the shaftlocated proximal the first opening; and a channel which gives access tothe guide wire lumen extending longitudinally between the first openingand the second opening.
 10. The catheter of claim 9, wherein the channelincludes an opening extending longitudinally between the first openingand the second opening in communication with the guidewire lumen.
 11. Abiliary rapid exchange catheter comprising: a biliary catheter sized forpassage within an endoscope including a shaft having a proximal end anda distal end; a tubular member having a proximal end, a distal end, anda guidewire lumen extending longitudinally therethrough, the tubularmember extending between a location proximate the distal end of theshaft and a location proximal of the distal end of the shaft; and adistal port in communication with the guidewire lumen, at a locationproximal of the distal end of the shaft.
 12. The biliary catheter ofclaim 11 wherein the distal port is located at the proximal end of thetubular member.
 13. The biliary catheter of claim 11, wherein theguidewire lumen extends between the proximal end and the distal end ofthe shaft.
 14. The biliary catheter of claim 11, wherein the guidewirelumen includes a weakened area extending longitudinally between thedistal port and the distal end of the shaft.
 15. The biliary catheter ofclaim 11, further including an ancillary lumen extending between theproximal end and the distal end of the shaft.
 16. The biliary catheterof claim 11, further including: a proximal port into the guidewire lumenat a location proximal of the distal port; and means extendinglongitudinally between the proximal port and the distal port forallowing a guidewire to be moved between a location exterior of theguidewire lumen and the guidewire lumen.
 17. The biliary catheter ofclaim 16, wherein the means for allowing the guidewire to be movedbetween a location exterior the guidewire lumen and the guidewire lumenincludes an open channel extending longitudinally between the proximalport and the distal port.
 18. The biliary catheter of claim 16, whereinthe means for allowing the guidewire to be moved between a locationexterior the guidewire lumen and the guidewire lumen includes a weakenedportion within the tubular member extending longitudinally between theproximal port and the distal port.
 19. The biliary catheter of claim 18,wherein the weakened portion is perforated.
 20. The biliary catheter ofclaim 11, wherein the tubular member is formed integral the shaft. 21.The biliary catheter of claim 11, wherein the tubular member is coupledto the shaft.
 22. A method of positioning a biliary catheter including ashaft having a proximal end and a distal end, within a patient'salimentary canal comprising the steps of: providing a guidewire lumenwithin the catheter, extending from a location proximal the distal endof the shaft to a location proximate the distal end of the shaft;providing a port through a sidewall of the shaft into the guidewirelumen, the port located distal of the proximal end of the shaft; andmoving a guidewire through the port, relative to the shaft.
 23. Themethod of claim 22, further comprising the step of advancing thecatheter over the guidewire.
 24. A method of exchanging a catheterduring a biliary endoscopic procedure comprising the steps of: passingan endoscope having a lumen extending longitudinally therethrough,through a patient's mouth into the alimentary canal; positioning adistal end of the endoscope proximate the opening into the biliary tree;passing a guidewire through the lumen of the endoscope; providing acatheter having a guidewire lumen carried by the shaft extending from alocation proximal a distal end of the shaft to a location proximate thedistal end of the shaft, including a first opening into the guidewirelumen located distal the proximal end of the shaft; and advancing thecatheter over the guidewire, wherein a proximal end of the guidewireexits the first opening.
 25. The method of claim 24, further includingthe step of retracting the catheter over the guidewire.
 26. The methodof claim 25, wherein the catheter is retracted over the guidewire untilthe opening is outside of the proximal end of the endoscope, wherein thecatheter has a weakened area extending longitudinally between theopening and the distal end of the catheter, further comprising the stepof peeling the catheter away from the guidewire.
 27. The method of claim24, wherein the catheter further includes a second opening into theguidewire lumen, with a channel extending longitudinally between thefirst opening and the second opening, further comprising the step ofpassing the guidewire through the channel until the guidewire exits thesecond opening.
 28. The catheter of claim 10, wherein the guidewirelumen has a diameter, and the channel opening has a width allowing forradial guidewire removal.
 29. The catheter of claim 17, wherein theguidewire lumen has a diameter, and the open channel has a widthallowing for radial guidewire removal.